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TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial

Comparison of Thera-togs Orthotics With Reciprocal Electrotherapy for Postural Stability in Spastic Diplegic Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05702632
Enrollment
15
Registered
2023-01-27
Start date
2022-07-15
Completion date
2022-12-30
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Brief summary

Children with diplegic cerebral palsy exhibit postural restrictions as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve balance and stability. As a result, the purpose of this study is to compare the effects of TheraTogs and reciprocal electrical stimulation on postural stability in children with diplegic CP.

Interventions

DEVICE1- Reciprocal electrical stimulation

A specialized programmable electrical stimulation device was used (Uniphy is the manufacturer of Phyaction787; Uniphy, Eindhoven, the Netherlands). The device has two channels that can alternatively stimulate two opposing groups of muscles (reciprocate).

DEVICETheraTogs orthotic treatment

A sleeveless top vest and two pairs of shorts with two thigh cuffs and limb cuffs each make up the TheraTogs strapping system which is applied to the children in the TheraTogs group. The TheraTogs suit is providing breathable, comfortable- Latex over the torso and thigh, as well as free toileting. For infection control and size fitting problems, participants are not allowed to share their TheraTogs with other patients. TheraTog's orthotic undergarment and strapping system were worn under their regular clothes, so it was neither distracting nor irritating.

PROCEDUREtraditional physical therapy program

Facilitation of balance and gait training

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* Diplegic children of both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade +1 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS).

Exclusion criteria

* If they had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pace- makers who were contraindicated by electrical stimula- tion, children with visual, auditory, or perceptual deficits, and children with seizures.

Design outcomes

Primary

MeasureTime frameDescription
postural stability3 monthsoverall stability indices had been measured by Biodex balance system

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026